At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
The inspection concluded with NIL observations
Rivaroxaban is used to treat venous thromboembolism
Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle
Prucalopride is prescribed for chronic idiopathic constipation
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
The company received one observation in the Form-483
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
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